Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001619437
Ethics application status
Approved
Date submitted
1/11/2016
Date registered
23/11/2016
Date last updated
21/01/2020
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
d-mannose for prophylaxis against Urinary tract Infection in Spinal Cord Injury
Scientific title
d-mannose for prophylaxis against Urinary tract Infection in SCI: Pilot Randomised control study
Secondary ID [1] 290435 0
none
Universal Trial Number (UTN)
U1111-1185-0605
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 300783 0
Neurogenic Bladder Dysfunction 300920 0
Condition category
Condition code
Renal and Urogenital 300613 300613 0 0
Other renal and urogenital disorders
Neurological 300732 300732 0 0
Other neurological disorders
Infection 300847 300847 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mode of administration of d mannose: Oral tablet, 1gm three times a day for 3 months.
Strategies to monitor adherence: Weekly check of medication chart and patient interview.
Intervention code [1] 296281 0
Treatment: Other
Comparator / control treatment
Control: Standard care for neurogenic bladder practised in the spinal unit. This includes, catheter care, early commencement of Intermittent catheterization program in appropriate case, hygiene, good fluid intake with the aim of 1.5 to 2 litres and education.
Control group
Active

Outcomes
Primary outcome [1] 300027 0
Rate ratio of UTI: Number of UTI/Total catheter days.
Number of UTI: This will be assessed by clinical symptoms like temperature more than 38, pain, urinary leakage with positive urine culture.
Catheter days: Total number of days patients needing to use catheter to manage their bladder.
Timepoint [1] 300027 0
3 months post commencement of study treatment.
Secondary outcome [1] 328836 0
Frequency ratio of CUTI: Number of episodes of CUTI between treatment and control group

Number of episode of UTI: Number of symptomatic Urinary tract infection (UTI), this will be assessed by clinical symptoms like fever (temperature more than 38), pain and urinary leakage with positive urine culture.
Timepoint [1] 328836 0
3 months post commencement of study treatment.
Secondary outcome [2] 329182 0
Acute transfer to tertiary Hospital for UTI between two groups.
Medical records and Hospital admission records will be reviewed.
Timepoint [2] 329182 0
3 months post commencement of study treatment.
Secondary outcome [3] 329553 0
Time to first UTI between both groups.
Medcial records review.
Timepoint [3] 329553 0
3 months post commencement of the study.
Secondary outcome [4] 378988 0
Temperature associated CUTI (UTI symptoms and associated temperature elevation) between groups
Temperature associated UTI: defined as temperature more than 38 which is measured using ear thermometer with positive urine culture.
Timepoint [4] 378988 0
3 months

Eligibility
Key inclusion criteria
Study population: patients admitted to Auckland Spinal Rehab Unit (ASRU).
Inclusion criteria: all new admission to spinal unit, neurogenic bladder needing catheter on admission.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Repeat admission, no evidence of neurogenic bladder on admission.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All the statistical analysis will be performed by using one or all of the statistical analytical software: R, SPSS and SAS.
Primary analysis: descriptive summary will be provided for each arm including patients ‘characteristics, number of UTI, time to first UTI within 3 months, need for acute transfer to ED, rate of CAUTI and rate of blood stream associated CAUTI.
Secondary analysis will provide descriptive summary for the safety outcomes by two groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/12/2016
Actual
1/03/2017
Date of last participant enrolment
Anticipated
21/12/2018
Actual
12/11/2018
Date of last data collection
Anticipated
28/02/2019
Actual
8/02/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 8362 0
New Zealand
State/province [1] 8362 0

Funding & Sponsors
Funding source category [1] 294838 0
Hospital
Name [1] 294838 0
Middlemore Hospital
Country [1] 294838 0
New Zealand
Funding source category [2] 294843 0
Hospital
Name [2] 294843 0
Auckland Spinal rehab unit
Country [2] 294843 0
New Zealand
Primary sponsor type
Individual
Name
Dr Suresh Subramanian
Address
Auckland Spinal Rehab unit
30 bairds Road
Otara
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 293762 0
None
Name [1] 293762 0
Address [1] 293762 0
Country [1] 293762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296224 0
Health and Disability Ethics Committee
Ethics committee address [1] 296224 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 296224 0
New Zealand
Date submitted for ethics approval [1] 296224 0
Approval date [1] 296224 0
20/10/2016
Ethics approval number [1] 296224 0
16/STH/125/AM01

Summary
Brief summary
Scientific studies have shown that urinary tract infection (UTI) occurs in 40 to 50% of people who sustain a spinal cord injury. Our local audit confirms a similar percentage at the Auckland Spinal Rehabilitation Unit (ASRU) with almost half of all our patients experiencing at least one episode of UTI following spinal cord injury. Our regular practice to reduce the risk of urinary tract infection is to increase fluid intake, provide appropriate care of the catheter system, ensure good hygiene with catheter use and, when possible, discontinue the indwelling catheter or discontinue and commence an intermittent catheterization program as soon as possible. Infections are treated with increasing water consumption and appropriate antibiotics after checking a urine culture.

We would like to know if d mannose reduces risk of UTI in people with spinal cord injury/impairment (SCI). D mannose, which is registered as a health supplement product in NZ, has been shown to reduce the risk of urinary tract infection (UTI) in women. D mannose is a natural sugar, which binds with bacteria and prevents adhesion of the bacteria to the bladder wall thus, presumably, reducing infection in the bladder. No studies have been done to determine D mannose’s effectiveness in prevention of UTI in the spinal cord injury population. To test the effectiveness of d mannose in reducing UTI in SCI, we have developed a pilot randomised control trial (RCT) at ASRU and Middlemore Hospital (MMH).
Trial website
Trial related presentations / publications
Public notes
What is the purpose of this study:

Scientific studies have shown that urinary tract infection (UTI) occurs in 40 to 50% of people who sustain a spinal cord injury. Our local audit confirms a similar percentage at the Auckland Spinal Rehabilitation Unit (ASRU) with almost half of all our patients experiencing at least one episode of UTI following spinal cord injury. Our regular practice to reduce the risk of urinary tract infection is to increase fluid intake, provide appropriate care of the catheter system, ensure good hygiene with catheter use and, when possible, discontinue the indwelling catheter or discontinue and commence an intermittent catheterization program as soon as possible. Infections are treated with increasing water consumption and appropriate antibiotics after checking a urine culture.

We would like to know if d mannose reduces risk of UTI in people with spinal cord injury/impairment (SCI). D mannose, which is registered as a health supplement product in NZ, has been shown to reduce the risk of urinary tract infection (UTI) in women. D mannose is a natural sugar, which binds with bacteria and prevents adhesion of the bacteria to the bladder wall thus, presumably, reducing infection in the bladder. No studies have been done to determine D mannose’s effectiveness in prevention of UTI in the spinal cord injury population. To test the effectiveness of d mannose in reducing UTI in SCI, we have developed a pilot randomised control trial (RCT) at ASRU and Middlemore Hospital (MMH).

What will my participation in the study involve?:

A randomised control trial is a study in which up to half of the participants do not receive treatment and the other half receive the trial drug, in this case, D mannose. Randomisation of the participants means either you will be in the control group (no drug group) or in the intervention group (D mannose group). If you are in the control group there will be no change in your management throughout your stay in Middlemore Hospital and at ASRU. If you are in the intervention group, you will receive 3 tablets of d mannose (UroFem) per day for the next 3 months. This medication will be charted in your medication chart and provided by the nursing staff just like other medications. If you miss taking a d mannose tablet, just continue with next scheduled dose. There is no need to take any extra doses the next day. A chart will be kept to record each tablet taken. We will monitor you closely for any negative/adverse effects. Previous studies have not identified any negative effects attributed to d mannose. Although unlikely to occur, we will watch for any change in blood sugar levels in diabetic patients. Monitoring for adverse/negative effects will be done on a weekly basis. Should you have any questions or concerns, you are encouraged to contact your nurse or the person monitoring the medication at any time. If you are discharged before the 3 month period ends, you will be provided with the remaining tablets for the 3 month period and a form for charting your tablets taken. You will be contacted by phone once a week until the end of the trial period to ensure you have had no negative effects and to track your dosing of the medication. Your GP will be informed of your participation in the study.

Participating in the trial is voluntary. Should you chose not to participate there will be no effect on your medical or rehabilitation care during your stay at MMH and/or ASRU if. You may withdraw from the study at any time. Your privacy will be maintained at all times. Your name and any identifying details will be removed (de-identified) to protect your privacy.

What are the possible benefits and risks of this study?

Potential benefit of this study: At the completion of the study we hope to identify that d mannose is an effective preventative treatment for UTI in people with SCI. If you would like a copy of the completed study with results, we will be happy to send you a copy.
Potential risk of this study: Considering d mannose is a dietary supplement and previous studies have not reported any significant adverse events, we expect minimal risk. However, considering d mannose is natural sugar, there may be a potential risk of changes in diabetic control and, even less likely, weight gain. Both possibilities will be monitored weekly during the course of this 3 month study.


Who pays for the study?

There is no cost to the participants. If discharged before the end of the 3 month trial, you will be provided with medication to complete the trial period.

What if something goes wrong?
In the unlikely event that you are injured due to this study, you will be eligible to apply for compensation from ACC, just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery. If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover.

What are my rights?
Whether or not you participate is your choice. If you do not wish to take part in the study, you do not need to give a reason. If you chose not to participate it will not affect the medical or rehabilitation care you receive.

What happens if I change my mind?
If you decide to take part now, but change your mind later, you can withdraw from the study at any time.
Attachments [1] 1206 1206 0 0
/AnzctrAttachments/371754-HDEC Letter 15NTB125 Approved EXP Application.pdf (Ethics approval)
Attachments [2] 1207 1207 0 0
/AnzctrAttachments/371754-HDEC Letter 16ST125AM01_Acknowledgement of reply to approval letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 70074 0
Dr Suresh Subramanian
Address 70074 0
Auckland Spinal rehab unit
30 Bairds Road
Otara
1640
Auckland
Country 70074 0
New Zealand
Phone 70074 0
+64 9 2709000
Fax 70074 0
+64 9 2709001
Email 70074 0
Sureshbabu.Subramanian@middlemore.co.nz
Contact person for public queries
Name 70075 0
Dr Suresh Subramanian
Address 70075 0
Auckland Spinal rehab unit
30 Bairds Road
Otara
1640
Auckland
Country 70075 0
New Zealand
Phone 70075 0
+64 9 2709000
Fax 70075 0
+64 9 2709001
Email 70075 0
Sureshbabu.Subramanian@middlemore.co.nz
Contact person for scientific queries
Name 70076 0
Dr Suresh Subramanian
Address 70076 0
Auckland Spinal rehab unit
30 Bairds Road
Otara
1640
Auckland
Country 70076 0
New Zealand
Phone 70076 0
+64 9 2709000
Fax 70076 0
+64 9 2709001
Email 70076 0
Sureshbabu.Subramanian@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Raw data sharing not included in initial ethics application, it will be saved but unable to share .


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
550Informed consent form    371754-(Uploaded-29-11-2018-13-53-20)-Study-related document.docx
571Ethical approval    371754-(Uploaded-14-12-2018-05-44-51)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.